MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE LP¿ CERVICAL DISC SYSTEM WITH STREAMLINED INSTRUMENTS; BIT, DRILL

Catalog Number	6975015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with herniated disc and underwent cervical arthroplasty with instrumentation surgery at c4-c5 levels.During surgery, while drilling through the drill guide, after the first hole was made, the drill bit sheared at the fluted end.The tip broke off inside the guide and the patient¿s endplate.No fragment of the instrument were remaining in the patient.The product came in contact with the patient.No patient complications were reported.

• Brand Name: PRESTIGE LP¿ CERVICAL DISC SYSTEM WITH STREAMLINED INSTRUMENTS
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8356950
• Report Number: 1030489-2019-00175
• Device Sequence Number: 1682874
• Product Code: HTW
• UDI-Device Identifier: 00643169777934
• UDI-Public: 00643169777934
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2025
• Device Catalogue Number: 6975015
• Device Lot Number: PZ17H005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR